FDA refusal charge
FDA refusal charge DIETARYLBL
Not identified as a dietary supplement
DIETARYLBL is the FDA import refusal charge for not identified as a dietary supplement; it cites sections 403(s)(2)(B) and 801(a)(3), misbranded of the FD&C Act. FDA recorded it on 1,139 refused shipment lines between October 2016 and October 8, 2026, most often for dietary supplements from Canada.
Data from FDA public records, last checked .
- 1,139
- refused shipment lines carry this charge
- 62
- countries of origin
- 1
- import alert names this charge
What DIETARYLBL means
The label appeared not to identify the product with the term "dietary supplement" (which may be modified with the name of an ingredient).
This restates FDA's statement. It says what the charge means, never why a particular shipment was refused.
- FD&C Act section
- 403(s)(2)(B)801(a)(3), misbranded
FDA's official statement
Copied unchanged from FDA's Refusal Charges reference table.
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it is a dietary supplement that appears to be misbranded within the meaning of Section 403(s)(2)(B) of the FD&C Act in that the label or labeling fails to identify the product by using the term "dietary supplement", which term may be modified with the name of such an ingredient.
Import alerts that name DIETARYLBL
The charge section of each alert names this code. An alert lists firms; a charge is the reason recorded on one refused line.
| Alert | Covers | Red | Green |
|---|---|---|---|
| 99-39 | Imported foods that appear to be misbranded | 677 |
Countries with the most DIETARYLBL refusals
Shipment lines carrying DIETARYLBL, by country of origin.
| Country | Lines | Share of DIETARYLBL |
|---|---|---|
| Canada | 213 | 19% |
| India | 130 | 11% |
| United Kingdom | 106 | 9% |
| Spain | 54 | 5% |
| China | 48 | 4% |
| Italy | 47 | 4% |
| Mexico | 43 | 4% |
| Malaysia | 32 | 3% |
| Hong Kong | 30 | 3% |
| South Korea | 30 | 3% |
Product categories with the most DIETARYLBL refusals
| Category | Lines | Share of DIETARYLBL |
|---|---|---|
| Vitamins, Minerals, Proteins, and Unconventional Dietary Specialties | 1,001 | 88% |
| Dietary Conventional Foods and Meal Replacements | 78 | 7% |
| Food Sweeteners (Nutritive) | 13 | 1% |
| Coffee and Tea | 10 | 1% |
| Vegetables and Vegetable Products (root and tuber vegetables, fungi) | 9 | 1% |
| Candy without Chocolate, Candy Specialties, and Chewing Gum | 6 | 1% |
| Spices, Flavors, and Salts | 4 | 0% |
| Soft Drinks and Waters | 3 | 0% |
| Filled Milk and Imitation Milk Products | 2 | 0% |
| Fruit and Fruit Products (pit, subtropical and tropical fruits) | 2 | 0% |
Latest DIETARYLBL refusals
The 20 most recent refused lines, through October 8, 2026, each with its FDA source.
| Date | Firm | Product | Charges | |
|---|---|---|---|---|
| Mae Khem Co LtdMae Sot, Thailand | Relish, vegetable based relish | DIETARYLBLNO ENGLISH | Source | |
| Mount Kailash Rejuvenation Centre Inc.Castries, Saint Lucia | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | DIETARYLBLDIETARYINGPLANT PART+3 | Source | |
| Mount Kailash Rejuvenation Centre Inc.Castries, Saint Lucia | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | DIETARYLBLDIETARYINGPLANT PART+3 | Source | |
| Biocare LtdEngland, United Kingdom | Foods with supplemental nutrients added, with or without artifical sweetners | DIETARYLBLLACKS N/CNO ENGLISH+2 | Source | |
| Biocare LtdEngland, United Kingdom | Foods with supplemental nutrients added, with or without artifical sweetners | DIETARYLBLLACKS N/CNO ENGLISH+2 | Source | |
| Biocare LtdEngland, United Kingdom | Foods with supplemental nutrients added, with or without artifical sweetners | DIETARYLBLLACKS N/CNO ENGLISH+2 | Source | |
| Pharma TamarRishon Letzion, Israel | Foods with supplemental nutrients added, with or without artifical sweetners | DIETARYLBLLACKS N/CNO ENGLISH+2 | Source | |
| Biogena GmbH and Co KGSalzburg, Austria | Foods with supplemental nutrients added, with or without artifical sweetners | DIETARYLBLLACKS N/CNO ENGLISH+2 | Source | |
| Biocare LtdEngland, United Kingdom | Foods with supplemental nutrients added, with or without artifical sweetners | DIETARYLBLLACKS N/CNO ENGLISH+2 | Source | |
| Merck, S.A. de C.V.Naucalpan De Juarez, Mexico | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | DIETARYLBLNO ENGLISHNUTRIT LBL | Source | |
| RmUnknown, Mexico | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | DIETARYLBLNO ENGLISHNUTRIT LBL | Source | |
| El Dragon de Oro de la SaludCalle Ocampo 3 Guanaj, Mexico | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | DIETARYLBLNO ENGLISHNUTRIT LBL | Source | |
| El Dragon de Oro de la SaludCalle Ocampo 3 Guanaj, Mexico | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | DIETARYLBLNO ENGLISHNUTRIT LBL | Source | |
| Laboratorio Industrial San CristobalSan Cristobal, Guatemala | Vitamin, n.e.c | DIETARYLBLNO ENGLISH | Source | |
| RmUnknown, Mexico | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | DIETARYLBLNO ENGLISHNUTRIT LBL | Source | |
| Acenzia Inc.Oldcastle, Canada | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | DIETARYLBLNUTRIT LBL | Source | |
| Drs Secret Worldwide Manufacturing Sdn BhdSeberang Perai Tengah, Malaysia | Coffee, n.e.c | DIETARYLBL | Source | |
| Effepharm (Shanghai) Co., LtdShanghai, China | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | LIST INGREDIETARYLBLLACKS FIRM+2 | Source | |
| Hemani InternationalKarachi, Pakistan | Herbals & botanicals (not teas), n.e.c | DIETARYLBLLACKS FIRMNUTRIT LBL+1 | Source | |
| Indus Life Sciences Pvt LtdChennai, India | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | DIETARYLBLLABELINGNUTRIT LBL+1 | Source |
Questions about DIETARYLBL
- What does DIETARYLBL mean on an FDA refusal?
- DIETARYLBL is the refusal charge “Not identified as a dietary supplement”. The label appeared not to identify the product with the term "dietary supplement" (which may be modified with the name of an ingredient).
- What law does DIETARYLBL cite?
- FDA's refusal charge table cites sections 403(s)(2)(B) and 801(a)(3), misbranded of the FD&C Act for DIETARYLBL. The table is the Refusal Charges reference file that FDA publishes with its Data Dashboard.
- Which countries have the most DIETARYLBL refusals?
- As of October 26, 2026, the countries with the most DIETARYLBL refusal lines are Canada (213), India (130) and United Kingdom (106). The full list with links is in the table on this page.
- Is there an FDA import alert for DIETARYLBL?
- Yes. One FDA import alert names DIETARYLBL as a charge code, including Import Alert 99-39 (Imported foods that appear to be misbranded). An import alert is a list of firms; a charge code is the reason recorded on one refused shipment line.
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